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Amending an Approved Protocol


Examples of substantial and non-substantial amendments

minor changes to the protocol or other study documentation, e.g. correcting errors, updating contact points, minor clarifications;; updates of ...

IRB Review Type - Amendments to Previously Approved Research ...

Whether an amendment will be submitted to reflect the protocol exception for future subjects. • Whether the current informed consent document ...

Protocols - Amending or Renewing a Protocol - Kuali Research

Once a protocol is approved the PI (if granted full access on the protocol) or Admin can initiate an Amendment or Renewal on the protocol if ...

Animal Protocol Amendments | Vertebrate Animal Research

Amending an approved Animal Protocol Any proposed modifications to an Animal Protocol must first be submitted to the IACUC and approved before performing ...

Submit an Amendment - Guide to Using RASS

All of your approved protocols that are available for amendment will be located under the Approved Protocols section on the left menu.

Series 408 Modifications to Approved Protocols | USU

This SOP describes modifications for protocols that have been reviewed via the Expedited or Convened IRB Review processes.

Tips for Protocol Amendments | ORCS

The goals of the amendment have to fit under the Scientific Goals of the protocol. Do not change the Scientific Goals to fit your amendment goals. If the goals ...

How to Change an Approved Animal Use Protocol

Approved AUPs may be modified with the submission of an amendment to the AUP through the iRIS program. The PI may change any section of the AUP, exclusive of ...

How to Amend a Protocol | Ethics in Human Research

An 'amendment' is a written description of (a) change(s) to an ongoing, currently approved protocol. Amendments include any change to the study documents ...

Protocols and Amendments for Animal Care and Use

If you need to make minor changes to a currently approved protocol, you can file an amendment using the online form, rather than submit an entirely new protocol ...

Protocol and Amendment Review - Office of Research and Innovation

New protocol submissions and amendment requests for approved protocols are submitted to the IACUC office by the Principal Investigator.

Common Clinical Trial Amendments, why they are submitted and ...

However, sometimes changes need to be made to the protocol or other trial documents after they have received regulatory approval. These changes are called ...

Protocol Amendments: Animal Care & Use: Compliance

Any significant change to an existing animal care and use protocol must be reviewed and approved by the Institutional Animal Care and Use Committee prior to ...

IACUC Protocol Amendments - Office of the Vice Provost for Research

In accordance with the Policy on Review of Amendments to Approved Protocols, any changes to a protocol must be approved by the IACUC prior to implementation ...

Amend an Approved Protocol | Research

Instructions for submitting an amendment to a protocol already populated in. eProtocol: 1) Log into eProtocol using your Net ID and password. 2) ...

Amending approved research - Human Research Protection Program

Requirements · Level of review and type of amendment · Investigator responsibilities · Emergency deviation from an approved IRB protocol · Anticipated deviation ...

Protocol & Amendment Review - Research - Washington University

Amendments can be submitted at any time and must be approved before the work described in the amendment may begin. The LAMPS system can only process one ...

Submitting a Protocol Amendment and Adding Personnel

Protocol Amendment Submission: To make changes to a current animal care and use protocol, a researcher must submit an amendment to the IACUC and have it ...

IRB: Amendments / Modifications to Protocols

All amendments and/or modifications to previously approved protocols must be reviewed and approved by the IRB prior to implementation except when necessary ...

Standard for Amendments and Other Protocol Changes - UNC Policies

1. Application Changes Handled by Email · 2. Significant Changes to an Approved Application Requiring the Submission of an Amendment · 3. · 4. · University Policies ...